Long-term safety and efficacy of indacaterol, a long-acting β2-agonist, in subjects with COPD: A randomized, placebo-controlled study

Kenneth R. Chapman, Stephen I. Rennard, Angeli Dogra, Roger Owen, Cheryl Lassen, Benjamin Kramer

Research output: Contribution to journalArticle

112 Citations (Scopus)

Abstract

Background: Indacaterol is an inhaled, long-acting β2- agonist providing 24-h bronchodilation with once-daily dosing in patients with COPD. Methods: Subjects with moderate to severe COPD who completed a 26-week, randomized, double-blind study were eligible for enrollment in an extension, during which treatment with double-blind indacaterol, 150 or 300 μg once daily, or placebo was continued for a further 26 weeks. The primary objective was to evaluate the long-term safety of indacaterol. Efficacy end points included trough (24 h postdose) FEV1 at 52 weeks, exacerbations, and health status (St. George Respiratory Questionnaire [SGRQ]). Results: Four hundred fifteen subjects participated in the extension. Adverse events, mostly mild or moderate, occurred in 76%, 77%, and 68% of subjects receiving indacaterol, 150 μg; indacaterol, 300 μg;and placebo, respectively. Serious adverse events occurred in 10.4%, 12.3%, and 10.5%, respectively. Indacaterol had no clinically significant effects on ECG findings (corrected QT interval) or on serum potassium or plasma glucose levels. Indacaterol increased trough FEV1 relative to placebo throughout the study (difference of ≥ 170 mL at week 52). No tolerance to its bronchodilator effect was detected. Indacaterol treatment was accompanied by significant reductions in COPD exacerbations (rate ratios compared with placebo, 0.62-0.64; P<.05) and as-needed albuterol use (1.2-1.4 puffs/d decrease, P<.001 compared with placebo). Health status improved with indacaterol treatment, with decreases from baseline in mean total SGRQ score generally >4 units. Conclusions: During 1 year of treatment, indacaterol was well tolerated and provided significant and well-maintained bronchodilation that was accompanied by improved clinical outcomes.

Original languageEnglish (US)
Pages (from-to)68-75
Number of pages8
JournalChest
Volume140
Issue number1
DOIs
StatePublished - Jul 1 2011

Fingerprint

Chronic Obstructive Pulmonary Disease
Placebos
Safety
indacaterol
Bronchodilator Agents
Double-Blind Method
Health Status
Potassium
Electrocardiography
Therapeutics
Glucose
Serum

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

Long-term safety and efficacy of indacaterol, a long-acting β2-agonist, in subjects with COPD : A randomized, placebo-controlled study. / Chapman, Kenneth R.; Rennard, Stephen I.; Dogra, Angeli; Owen, Roger; Lassen, Cheryl; Kramer, Benjamin.

In: Chest, Vol. 140, No. 1, 01.07.2011, p. 68-75.

Research output: Contribution to journalArticle

Chapman, Kenneth R. ; Rennard, Stephen I. ; Dogra, Angeli ; Owen, Roger ; Lassen, Cheryl ; Kramer, Benjamin. / Long-term safety and efficacy of indacaterol, a long-acting β2-agonist, in subjects with COPD : A randomized, placebo-controlled study. In: Chest. 2011 ; Vol. 140, No. 1. pp. 68-75.
@article{ee9944063cd8450e833772b2aa08ea41,
title = "Long-term safety and efficacy of indacaterol, a long-acting β2-agonist, in subjects with COPD: A randomized, placebo-controlled study",
abstract = "Background: Indacaterol is an inhaled, long-acting β2- agonist providing 24-h bronchodilation with once-daily dosing in patients with COPD. Methods: Subjects with moderate to severe COPD who completed a 26-week, randomized, double-blind study were eligible for enrollment in an extension, during which treatment with double-blind indacaterol, 150 or 300 μg once daily, or placebo was continued for a further 26 weeks. The primary objective was to evaluate the long-term safety of indacaterol. Efficacy end points included trough (24 h postdose) FEV1 at 52 weeks, exacerbations, and health status (St. George Respiratory Questionnaire [SGRQ]). Results: Four hundred fifteen subjects participated in the extension. Adverse events, mostly mild or moderate, occurred in 76{\%}, 77{\%}, and 68{\%} of subjects receiving indacaterol, 150 μg; indacaterol, 300 μg;and placebo, respectively. Serious adverse events occurred in 10.4{\%}, 12.3{\%}, and 10.5{\%}, respectively. Indacaterol had no clinically significant effects on ECG findings (corrected QT interval) or on serum potassium or plasma glucose levels. Indacaterol increased trough FEV1 relative to placebo throughout the study (difference of ≥ 170 mL at week 52). No tolerance to its bronchodilator effect was detected. Indacaterol treatment was accompanied by significant reductions in COPD exacerbations (rate ratios compared with placebo, 0.62-0.64; P<.05) and as-needed albuterol use (1.2-1.4 puffs/d decrease, P<.001 compared with placebo). Health status improved with indacaterol treatment, with decreases from baseline in mean total SGRQ score generally >4 units. Conclusions: During 1 year of treatment, indacaterol was well tolerated and provided significant and well-maintained bronchodilation that was accompanied by improved clinical outcomes.",
author = "Chapman, {Kenneth R.} and Rennard, {Stephen I.} and Angeli Dogra and Roger Owen and Cheryl Lassen and Benjamin Kramer",
year = "2011",
month = "7",
day = "1",
doi = "10.1378/chest.10-1830",
language = "English (US)",
volume = "140",
pages = "68--75",
journal = "Chest",
issn = "0012-3692",
publisher = "American College of Chest Physicians",
number = "1",

}

TY - JOUR

T1 - Long-term safety and efficacy of indacaterol, a long-acting β2-agonist, in subjects with COPD

T2 - A randomized, placebo-controlled study

AU - Chapman, Kenneth R.

AU - Rennard, Stephen I.

AU - Dogra, Angeli

AU - Owen, Roger

AU - Lassen, Cheryl

AU - Kramer, Benjamin

PY - 2011/7/1

Y1 - 2011/7/1

N2 - Background: Indacaterol is an inhaled, long-acting β2- agonist providing 24-h bronchodilation with once-daily dosing in patients with COPD. Methods: Subjects with moderate to severe COPD who completed a 26-week, randomized, double-blind study were eligible for enrollment in an extension, during which treatment with double-blind indacaterol, 150 or 300 μg once daily, or placebo was continued for a further 26 weeks. The primary objective was to evaluate the long-term safety of indacaterol. Efficacy end points included trough (24 h postdose) FEV1 at 52 weeks, exacerbations, and health status (St. George Respiratory Questionnaire [SGRQ]). Results: Four hundred fifteen subjects participated in the extension. Adverse events, mostly mild or moderate, occurred in 76%, 77%, and 68% of subjects receiving indacaterol, 150 μg; indacaterol, 300 μg;and placebo, respectively. Serious adverse events occurred in 10.4%, 12.3%, and 10.5%, respectively. Indacaterol had no clinically significant effects on ECG findings (corrected QT interval) or on serum potassium or plasma glucose levels. Indacaterol increased trough FEV1 relative to placebo throughout the study (difference of ≥ 170 mL at week 52). No tolerance to its bronchodilator effect was detected. Indacaterol treatment was accompanied by significant reductions in COPD exacerbations (rate ratios compared with placebo, 0.62-0.64; P<.05) and as-needed albuterol use (1.2-1.4 puffs/d decrease, P<.001 compared with placebo). Health status improved with indacaterol treatment, with decreases from baseline in mean total SGRQ score generally >4 units. Conclusions: During 1 year of treatment, indacaterol was well tolerated and provided significant and well-maintained bronchodilation that was accompanied by improved clinical outcomes.

AB - Background: Indacaterol is an inhaled, long-acting β2- agonist providing 24-h bronchodilation with once-daily dosing in patients with COPD. Methods: Subjects with moderate to severe COPD who completed a 26-week, randomized, double-blind study were eligible for enrollment in an extension, during which treatment with double-blind indacaterol, 150 or 300 μg once daily, or placebo was continued for a further 26 weeks. The primary objective was to evaluate the long-term safety of indacaterol. Efficacy end points included trough (24 h postdose) FEV1 at 52 weeks, exacerbations, and health status (St. George Respiratory Questionnaire [SGRQ]). Results: Four hundred fifteen subjects participated in the extension. Adverse events, mostly mild or moderate, occurred in 76%, 77%, and 68% of subjects receiving indacaterol, 150 μg; indacaterol, 300 μg;and placebo, respectively. Serious adverse events occurred in 10.4%, 12.3%, and 10.5%, respectively. Indacaterol had no clinically significant effects on ECG findings (corrected QT interval) or on serum potassium or plasma glucose levels. Indacaterol increased trough FEV1 relative to placebo throughout the study (difference of ≥ 170 mL at week 52). No tolerance to its bronchodilator effect was detected. Indacaterol treatment was accompanied by significant reductions in COPD exacerbations (rate ratios compared with placebo, 0.62-0.64; P<.05) and as-needed albuterol use (1.2-1.4 puffs/d decrease, P<.001 compared with placebo). Health status improved with indacaterol treatment, with decreases from baseline in mean total SGRQ score generally >4 units. Conclusions: During 1 year of treatment, indacaterol was well tolerated and provided significant and well-maintained bronchodilation that was accompanied by improved clinical outcomes.

UR - http://www.scopus.com/inward/record.url?scp=79960405028&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79960405028&partnerID=8YFLogxK

U2 - 10.1378/chest.10-1830

DO - 10.1378/chest.10-1830

M3 - Article

C2 - 21349928

AN - SCOPUS:79960405028

VL - 140

SP - 68

EP - 75

JO - Chest

JF - Chest

SN - 0012-3692

IS - 1

ER -